Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy

Pfizer

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: Nelfinavir mesylate, 625 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246610

A4301017

Details and patient eligibility

About

This study is an evaluation of the safety of 625 mg formulation when administered to HIV-infected pregnant women from their second trimester through six weeks postpartum. The study will also evaluate the pharmacokinetics of VIRACEPT

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV infection
• Second trimester of pregnancy

Exclusion criteria

• Major current or prior history of obstetrical complications
• Serious current medical diseases
• Evidence of HIV virus resistance to antiretroviral agents

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Open-label

Experimental group

Description:

Non-randomized, open-label, single-arm

Treatment:

Drug: Nelfinavir mesylate, 625 mg